Nutritional Counseling Impact on Ulcerative Colitis Patients

NCT06824038 | Completed

• 1 other identifier: MD-53-2023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

randomized clinical trial aimed to find whether, In ulcerative colitis patients, nutrition counseling is associated with improved nutritional status. objectives:

1. 1.Asses the nutritional status and quality of life among a sample of UC patients attending the NHTMRI outpatient clinic.
2. 2.Provide nutritional counseling for the randomly allocated intervention group
3. 3.Evaluate the effect of the nutritional counseling on nutritional status, quality of life and disease progression.
4. 4.Inclusion criteria: patients with moderate Ulcerative Colitis, in active phase. Adults aged 18-60, of both sexes Patients in the intervention group will receive a counseling session then instructs on the subsequent follow up dates. Each patient of the intervention group is scheduled to receive weekly session, according to settled appointments; while the control arm will receive the regular service at the clinic.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (9)

• nutritional status

  weight in kilograms ,

  three months

• nutritional status

  body mass index in kg/meter square.

  three months

• nutritional status

  Nutritional risk screening: The NRS-2002 score is a sum of the total of the nutritional score, severity of disease score and the age adjustment score. The total number of points ranges from 0 to 7. Patients with a score of 3 and more are suggested to have problems with nutrition.

  three months

• nutritional status

  Hand grip strength measured in kilograms.

  three months

• nutritional status

  Skin fold thickness in millimeters.

  three months

• dietary habits

  Dietary habits questionnaire to asses the cooking methods and daily habits.

  three months

• dietary habits

  Dietary habits questionnaire to asses the cooking methods and daily habits, and, The 24 hour recall to asses food groups intake, macro and micronutrients consumption.

  three months

• dietary habits

  The 24 hour recall to asses food groups intake, macro and micronutrients consumption.

  three months

• quality of life score

  asses the QoL through the Short Inflammatory Bowel Disease Questionnaire SIBDQ score. It consists of 10 questions. Each question is scored by a 7-point Likert scale, ranging from 1 (a severe problem) to 7 (not a problem at all), giving an absolute SIBDQ score ranging from 10 (poor health related quality of life "HRQoL") to 70 (optimal HRQoL).

  three months

Study Arms (2)

intervention group

EXPERIMENTAL

Patients with moderate Ulcerative Colitis, in active phase, Ages: Adults aged 18-60, of both sexes. Intervention: will receive nutritional counseling sessions ,nd weekly follow-up through clinic vists and mobile phones and messaging

Behavioral: nutritional counseling

control group

NO INTERVENTION

Patients with moderate Ulcerative Colitis, in active phase. Adults aged 18-60, of both sexes. will receive regular care of the clinic.

Interventions

nutritional counseling BEHAVIORAL

Nutritional counseling based on the nutritional assessment of each patient. Each patient will receive a package of: i. A booklet that contains the whole instructions and dietary records to help in remembering information and record their application of the plan. ii. A tailored diet menu adjusted according to the required calories of the patient calculated by the Harris Benedict equation, considering the patient preferences, individualized requirements and with choices suitable for different economic classes.

intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with moderate Ulcerative Colitis, in active phase.
• Adults aged 18-60, of both sexes

You may not qualify if:

• Patients with acute fulminant colitis.
• Patient with weight loss \> 5% in the last month, and \>10% weight loss in the last 6 months.

Sponsors & Collaborators

• Rahma Mohammed Medhat Ali: lead

Study Sites (1)

National Hepatology and Tropical Medicine research institute

Cairo, Egypt

Location

Related Publications (2)

• Dryden GW, Dryden SM. Synergistic Benefits of Dietary Strategies in the Management of IBD. Curr Gastroenterol Rep. 2025 Dec;27(1):8. doi: 10.1007/s11894-024-00949-1. Epub 2024 Dec 19.

  PMID: 39702516 BACKGROUND

• Jaramillo AP, Abaza A, Sid Idris F, Anis H, Vahora I, Moparthi KP, Al Rushaidi MT, Muddam M, Obajeun OA. Diet as an Optional Treatment in Adults With Inflammatory Bowel Disease: A Systematic Review of the Literature. Cureus. 2023 Jul 18;15(7):e42057. doi: 10.7759/cureus.42057. eCollection 2023 Jul.

  PMID: 37601990 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Rahma M Ali, Msc

  Faculty of medicine, Port Said University

  PRINCIPAL INVESTIGATOR

• Maha A Al Ghobashy, MD

  Cairo University

  STUDY DIRECTOR

• Marwa R Salem, MD

  Cairo University

  STUDY DIRECTOR

• Kamal A El Atrebi, MD

  National hepatology and tropical medicine research institute

  STUDY CHAIR

• Mona Hegazy, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 13, 2025
• Study Start: September 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: October 15, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)